ISO 13485:2016 • FDA QMSR Compliance • Deterministic CAPA Scoping

Continuous Design Traceability from User Need to Field Complaint

Static Excel traceability matrices become obsolete hours after being signed off. PMX OS maintains a live, mathematically verified knowledge graph linking design controls, ISO 14971 risk nodes, bench testing, and post-market CAPA investigations.

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Real-Time Quality Governance

CardioSense Pro v3.8.2 Active Quality Health Metrics

Zero manual document reconciliation. Every metric is computed dynamically from graph topological integrity.

100%

User Need Coverage

91 / 100

System Readiness Score

1

Active Verification Delta

0

Orphan Requirements

The Root Cause Bottleneck

Deterministic CAPA Blast Radius Scoping

When a hospital reports a post-market clinical complaint, quality engineering must trace the root cause back to manufacturing lots, design requirements, and risk mitigations.

In legacy systems, this requires 3 weeks of manual archaeology: reading PDFs, cross-referencing paper DMRs, and scheduling emergency cross-functional meetings. Quality often either over-corrects (recalling unimpacted lots) or under-corrects (missing a common component vulnerability across sibling products).

PMX OS isolates root causes deterministically by traversing semantic graph paths from complaint intake straight to physical BOM parts and risk lines.

Real-World Quality Case

CAPA-2026-088: Contact Thermistor Drift

A clinic reported sporadic warmth during a 72-hour Holter recording. Quality initiated CAPA-2026-088.

[QUERY] Root Cause Blast Radius for Sensor S-18

• Affected Finished Good: CardioSense Pro v3.8.2

• Failure Mode: Resistance tolerance drift at ambient >32°C

• Mitigating Change: CHG-1024 (Substitute S-22)

• Verification Status: V-0183 Thermal Dissipation PASSED

CAPA investigation completed and closed with full regulatory justification in under 48 hours.

Regulatory Modernization

Unified Compliance with ISO 13485:2016 & FDA QMSR

The FDA Quality Management System Regulation (QMSR) fully harmonizes Part 820 with ISO 13485. PMX OS operationalizes every clause natively.

Regulatory Standard Clause	Compliance Mandate	PMX OS Automated Graph Control
ISO 13485 Clause 7.3.2 / QMSR	Design & Development Planning and Inputs	Structured requirement schemas with automatic bidirectional parent-child linkages
ISO 13485 Clause 7.3.6 / QMSR	Design Verification & Validation	Cryptographic evidence binding tying test raw data directly to acceptance criteria
ISO 14971 Clause 7 / QMSR	Risk Management & Risk Control Measures	Every hazard (RSK) is mapped to an active design input and verifiable test protocol
ISO 13485 Clause 8.2.2 / QMSR	Complaint Handling & Post-Market Feedback	Automated blast radius tracing from MAUDE/adverse signals to design control nodes

Inspection Readiness

Never Spend Weeks Preparing for an Audit Again

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